SPECTRANETICS LEAD LOCKING DEVICE UNAVAILABLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-17 for SPECTRANETICS LEAD LOCKING DEVICE UNAVAILABLE manufactured by The Spectranetics Corporation.

Event Text Entries

[184076448] Patient's weight unavailable from facility. Device model, lot number, catalog number, expiration date, udi unavailable. 510k number unavailable because device lot number unavailable. Device manufacture date unavailable because device lot number unavailable.
Patient Sequence No: 1, Text Type: N, H10

[184076449] A lead extraction procedure commenced to remove a right ventricular (rv)pacing lead due to occlusion, and being upgraded to an icd lead. There was a right atrial (ra) lead, a left ventricular (lv) lead and a second rv lead present in the patient as well, but were not targeted for lead extraction. Multiple spectranetics devices along with concomitant devices were in use during the procedure: spectranetics 14f and 16f glidelight laser sheaths, tightrail rotating dilator sheath, lead locking devices (lld's) and cook medical evolution device. An lld was placed within the rv lead targeted for extraction. During the extraction attempt, the physician reportedly used a 14f glidelight first. Due to stalled progress, he then used a cook evolution device, followed by an 11f tightrail device, and lastly a 16f glidelight device. The physician was able to free the helix of the lead, and significant adhesions were noted on the end of the lead. He attempted to pull the lead back through the glidelight device in order to remove it. However, as he was pulling the lead back, the end of the lead flipped around, but ultimately was successfully removed. After the rv lead was extracted, the patient's blood pressure dropped. Rescue efforts commenced immediately, including sternotomy. Perforations to the superior vena cava (svc) and to the right atrial appendage were discovered (please see mdr 1721279-2020-00052 which captures the svc injury and the tightrail device was in use in the area of injury). Interventions were successful and the patient survived the procedure. The physician could not be certain, but thinks that the tightrail or the evolution devices may have caused or contributed to the svc tear. The physician believes that the helix of the rv lead actually tore the atrial appendage when it flipped around during lead removal. This report captures the lld device, which was being used as the traction platform to aid in rv lead removal when the helix of the lead flipped around and was thought to have created the right atrial appendage injury.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1721279-2020-00054
• MDR Report Key: 9842146
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-03-17
• Date of Report: 2020-02-24
• Date of Event: 2020-02-21
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-24
• Date Added to Maude: 2020-03-17
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS. BARBARA CREEL
• Manufacturer Street: 9965 FEDERAL DRIVE
• Manufacturer City: COLORADO SPRINGS CO 80921
• Manufacturer Country: US
• Manufacturer Postal: 80921
• Manufacturer Phone: 719447-246
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Generic Name: LLD
• Product Code: DRB
• Date Received: 2020-03-17
• Model Number: UNAVAILABLE
• Catalog Number: UNAVAILABLE
• Lot Number: UNAVAILABLE FROM FACILITY
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: THE SPECTRANETICS CORPORATION
• Manufacturer Address: 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-03-17
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention	2020-03-17